Catalog Number

01012

Brand Name

Kimono

Version/Model Number

Thin

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

26f5dbdb-4a37-478d-98bd-bbd089e109d2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Package DI Number

10016169010122

Quantity per Package

8

Contains DI Package

20016169010129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON